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Interaction with registrants agreed on during workshop on Substance Evaluation

ECHA/NA/12/28
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Media enquiries: ECHA Press

Participants from the Member States' Competent Authorities (MSCAs), ECHA and observers from Stakeholder organisations agreed on preferred ways to interact early with registrants during the substance evaluation process.

Helsinki, 07 June 2012 – During the Substance Evaluation workshop organised at ECHA's premises in Helsinki from 4 to 5 June, the MSCAs and representatives of ECHA's accredited Stakeholders focused on the substance evaluation procedures. It was agreed that the evaluating Member State should initiate informal interaction with the registrants of the concerned CoRAP substance as early as possible in the substance evaluation process. In order to keep such interaction manageable some general principles were laid down in agreement with the industry stakeholders:

  • The evaluating Member State should be in contact with the lead registrant to start the interaction as soon as it is evident that the Member State will be the evaluating Member State.
  • The registrants should organise themselves for the dialogue so that one registrant, presumably the lead registrant, is coordinating the views and handling the contacts with the evaluating Member State.
  • The interaction during the evaluation phase should only focus on the technical information of the substance.
  • If the registrants plan to update their dossier, this should be done before the substance evaluation has started due to the stringent legal timelines making it difficult to take the new information into account during the process. If updating the dossier is not possible before starting the substance evaluation, the lead registrant should clearly communicate to the evaluating Member State the plans for the update and the type of new information.

The workshop participants also agreed to recommend that for the formal commenting steps in the decision making process regarding possible information requests as laid down in REACH, registrants of the same substance should coordinate their views and submit only one set of comments on behalf of all of them.

During the workshop, the preparation of the next Community Rolling Action Plan (CoRAP) update, allocation of substances to the Member States and the selection criteria for substances that will be evaluated were also discussed.

It was also concluded that there is no immediate need to revise the prioritisation criteria for the selection of CoRAP substances that were adopted in May 2011. Instead, ECHA along with the Member States and Stakeholders will further reflect the ideas for using the current criteria in a flexible way.

A draft for the next CoRAP update is planned to be published by the end of October, and the publication of the adopted CoRAP update is foreseen for the end of March 2013. It is important to note that the substances on the list are not proposed for restriction or to be banned but the only purpose of the evaluation is to clarify whether their use poses a risk to human health or the environment. If necessary, the evaluation can result in a request for further information from the registrants of the substance to verify the suspected concern.

The evaluation may conclude that the risks are sufficiently under control with the measures already in place or it may lead to a separate proposal on EU-wide risk management measures.

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